Photobiomodulation in Dry Age Related Macular Degeneration

Официальное название

Outcomes of Photobiomodulation in DRy Age Related macUlar Degeneration: a proSpective multicEnter raNdomized Controlled (DRUSEN) Study

Обзор

The goal of this clinical trial is to evaluate effects of consecutive Yellow and Red Light Emitting Diode photobiomodulation in dry age-related macular degeneration (AMD). The main questions it aims to answer are: * Is Yellow and Red Light Emitting Diode photobiomodulation effective in decreasing drusen volume in patients affected by dry AMD? * Does Yellow and Red Light Emitting Diode photobiomodulation increase visual acuity and contrast sensitivity in patients affected by dry AMD? Participants will be randomly assigned to a treatment or a sham group. Treatment consists in two cycles with two phases each: * 1st phase: 300 seconds of continuous Yellow light with eyes closed + 60 seconds of pulsed Yellow light with eyes opened; * 2d phase: 300 seconds of continuous Red light with eyes closed + 60 seconds of pulsed Red light with eyes opened. Cycle 1 consists of 8 sessions (two PBM per week for 4 weeks) and cycle 2 consists of 6 sessions (two PBM per week for 3 weeks). Researchers will compare patients in the treatment group to those in the sham group to evaluate differences in objective signs and subjective symptoms of dry AMD.

Вмешательства

• Устройство Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)
  Each session consists of: * 1st phase: 300 seconds of continuous Yellow light (eyes closed) + 60 seconds of pulsed Yellow light (eyes opened) * 2nd phase: 300 seconds of continuous Red light(eyes closed) + 60 seconds of pulsed Red light (eyes opened). Cycle 1: 8 sessions (two PBM per week for 4 weeks); Cycle 2: 6 sessions (two PBM per week for 3 weeks).
• Устройство Sham Mask
  Low light emission mask (Sham Mask, Espansione group, Bologna, Italy)

Первичные конечные точки

• Best Corrected Visual Acuity variation [Срок оценки: 1 month, 2 months and 4 months after each cycle]
• Drusen Volume Variation [Срок оценки: 1 month, 2 months and 4 months after each cycle]
• Contrast sensitivity variation [Срок оценки: 1 month, 2 months and 4 months after each cycle]

Критерии участия

Критерии включения

• BCVA ETDRS > 40 L ETDRS at 4 meters
• Diagnosis of DRY AMD AREDS grade 2-3
• Ability to communicate well with the investigator and able to understand and comply with the requirements of the study

Критерии исключения

• Concomitant epilepsy
• Neurological diseases
• Psychiatric pathologies
• Herpes virus infections
• Dense cataract
• Pregnancy
• Other significant ocular and/or retinal diseases

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Италия · 3 центра

• Università degli Studi di Ferrara — Ferrara
• Università degli studi della Campania Luigi Vanvitelli — Naples
• Università di Torino — Torino

Turkey (Türkiye) · 2 центра

• University of Ankara — Ankara
• Koç University Hospital — Koç

Франция · 1 центр

• University of Paris — Paris

Великобритания · 1 центр

• Earlam and Christopher — Taunton

Публикации

• Borrelli E, Coco G, Pellegrini M, Mura M, Ciarmatori N, Scorcia V, Carnevali A, Lucisano A, Borselli M, Rossi C, Reibaldi M, Ricardi F, Vagge A, Nicolo M, Forte P, Cartabellotta A, Hasanreisoglu M, Kesim C, Demirel S, Yanik O, Bernabei F, Rothschild PR, Farrant S, Giannaccare G. Safety, Tolerability, and Short-Term Efficacy of Low-Level Light Therapy for Dry Age-Related Macular Degeneration. Ophth PMID 39271642

Идентификаторы

NCT: NCT06046118 · PBM AMD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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